- Email: [email protected]
Expiry-date tampering
CORRESPONDENCE
on safety incidents, ensuring that system error, rather than individual error, is analysed and acted on. Seven Steps to Patient Safety, our new good practice guide, promotes the message that staff need to feel confident that they will not be punished when reporting that mistakes have been made. A key component of our work is to create a sea change in NHS thinking, moving away from a punitive culture of apportioning blame to individuals to one where we learn from our mistakes. With our network of 31 patient safety managers across England and Wales, the NPSA will provide leadership, training, support, and advice to all within the health service. Our role is to help NHS staff by driving improvements to patients’ safety, ensuring that resources remain in the front line, and giving the public renewed confidence in their healthcare professionals. We believe that improvements to patients’ care will inevitably be the result. *Sue Osborn, Susan Williams Joint Chief Executive, National Patient Safety Agency, 4–8 Maple Street, London W1T 5HD, UK (e-mail: [email protected]) 1
Lanier DC, Roland M, Burstin H, Knottnerus JA. Doctor performance and public accountability. Lancet 2003; 362: 1404–08.
Expiry-date tampering Sir—Counterfeit drugs are causing increasing problems in the delivery of quality health care, especially in southeast Asia, where up to 38% of samples of artesunate contain no active drug, and in Peru where up to 80% of drugs are estimated to be fake.1,2 The relative lack of central control and regulation over the quality of drug supply, and the fact that relatives rather than the hospitals or physicians are responsible for obtaining sources of medication for the patient from a vast number of different outlets, generates a situation that counterfeiters can easily exploit.3 Pharmaceutical companies have responded by developing increasingly sophisticated tablet and packaging design (eg, the use of holograms). However, despite increasing the technical difficulties and costs involved in counterfeiting, these methods are already beginning to be matched by the fraudsters, and fakes can be difficult to spot even with detailed examination.4 We recently discovered evidence of a simpler, yet equally effective,
172
Pharmacists, nurses, and physicians, as well as companies and their distributors, need to remain vigilant to this threatening new version of counterfeit products. *Jeremy N Day, Tran Tinh Hien, Jeremy Farrar Oxford University Clinical Research Unit, Hospital for Tropical Diseases, 190 Ben Ham Tu, Quan 5, Ho Chi Minh City, Vietnam (e-mail: [email protected]) 1
2
3
4
Tampered expiry dates on insert and foilstrip packaging of BM-Lactate strip test
method of fraud that could have serious consequences for patients. We have found that measurement of lactate concentrations in blood and cerebrospinal fluid is very useful in aiding diagnosis (causes of meningitis), and assessing prognosis and response to treatment in severe malaria and sepsis.5 Out of normal working hours, we use a handheld BM meter (Boehringer Mannheim Accusport 1488767) with BM-Lactate test strips (Roche Diagnostics, Mannheim, Germany) for this purpose. Recently we noticed a discrepancy between the clinical picture, the readings obtained with this meter, and those obtained from our internal quality control. Close inspection of the BM-Lactate test strips revealed that the expiry dates on the strips themselves, the package inserts, and the boxes had been tampered with, such that they appeared to expire in 2004, when in fact they had expired in 2002 (figure). After thorough discussions with all parties involved, this expiry date alteration clearly arose when the product was distributed via loose networks out of the control of the parent companies or licensing authorities. This finding could have implications for how companies distribute and sell their products in certain markets. Compared with drug counterfeiting, this method of fraud is cheap and technically simple, yet at least as difficult to spot and potentially dangerous, particularly if applied to drugs as well as to consumables. The quality of the changes suggests that this fraud is well organised and potentially widespread.
5
Kapp C. Counterfeit drug problem “underestimated”, says conference. Lancet 2002; 360: 1080. Newton P, Proux S, Green M, et al. Fake artesunate in southeast Asia. Lancet 2001; 357: 1948–50. Chatterjee P. India’s trade in fake drugs— bringing the counterfeiters to book. Lancet 2001; 357: 1776. Newton PN, Dondorp A, Green M, Mayxay M, White NJ. Counterfeit artesunate antimalarials in southeast Asia. Lancet 2003; 362: 169. Day NP, Phu NH, Mai NT, et al. The pathophysiologic and prognostic significance of acidosis in severe adult malaria. Crit Care Med 2000; 28: 1833–40.
Sir—Roche Diagnostics is extremely concerned about the discovery of fraud involving one of our products in Vietnam. We have been in communication with Jeremy Day and colleagues, and share their alarm at the discovery of product tampering. Counterfeiting and package tampering are issues that health-care suppliers in Asia are grappling with now. Thanks to the vigilance of the staff at the Hospital for Tropical Diseases, the removal of expiry dates and replacement with new, false dates was discovered. Roche Diagnostics views the fraudulent alteration of expiry dates on diagnostic kits extremely seriously. As a result of local investigations in Vietnam, we believe we have identified the external party responsible for the expiry alteration and are working with local authorities and regulators to address the problem. We have also redefined local logistical processes to minimise the risk of similar fraudulent alterations in the future. Although we hope that no other health-care supplier or medical professional will face the situation that we and the staff at the Hospital for Tropical Diseases in Vietnam have encountered, we feel it is vital to ensure that other members of the industry are informed of incidents such as this and are able to heighten their own vigilance to ensure that patients are not harmed by these fraudulent tactics. Graham Watt Roche Diagnostics Asia Pacific, 15 Rakino Way, Mt Wellington, Auckland, New Zealand (e-mail: [email protected])
THE LANCET • Vol 363 • January 10, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet publishing Group.
on safety incidents, ensuring that system error, rather than individual error, is analysed and acted on. Seven Steps to Patient Safety, our new good practice guide, promotes the message that staff need to feel confident that they will not be punished when reporting that mistakes have been made. A key component of our work is to create a sea change in NHS thinking, moving away from a punitive culture of apportioning blame to individuals to one where we learn from our mistakes. With our network of 31 patient safety managers across England and Wales, the NPSA will provide leadership, training, support, and advice to all within the health service. Our role is to help NHS staff by driving improvements to patients’ safety, ensuring that resources remain in the front line, and giving the public renewed confidence in their healthcare professionals. We believe that improvements to patients’ care will inevitably be the result. *Sue Osborn, Susan Williams Joint Chief Executive, National Patient Safety Agency, 4–8 Maple Street, London W1T 5HD, UK (e-mail: [email protected]) 1
Lanier DC, Roland M, Burstin H, Knottnerus JA. Doctor performance and public accountability. Lancet 2003; 362: 1404–08.
Expiry-date tampering Sir—Counterfeit drugs are causing increasing problems in the delivery of quality health care, especially in southeast Asia, where up to 38% of samples of artesunate contain no active drug, and in Peru where up to 80% of drugs are estimated to be fake.1,2 The relative lack of central control and regulation over the quality of drug supply, and the fact that relatives rather than the hospitals or physicians are responsible for obtaining sources of medication for the patient from a vast number of different outlets, generates a situation that counterfeiters can easily exploit.3 Pharmaceutical companies have responded by developing increasingly sophisticated tablet and packaging design (eg, the use of holograms). However, despite increasing the technical difficulties and costs involved in counterfeiting, these methods are already beginning to be matched by the fraudsters, and fakes can be difficult to spot even with detailed examination.4 We recently discovered evidence of a simpler, yet equally effective,
172
Pharmacists, nurses, and physicians, as well as companies and their distributors, need to remain vigilant to this threatening new version of counterfeit products. *Jeremy N Day, Tran Tinh Hien, Jeremy Farrar Oxford University Clinical Research Unit, Hospital for Tropical Diseases, 190 Ben Ham Tu, Quan 5, Ho Chi Minh City, Vietnam (e-mail: [email protected]) 1
2
3
4
Tampered expiry dates on insert and foilstrip packaging of BM-Lactate strip test
method of fraud that could have serious consequences for patients. We have found that measurement of lactate concentrations in blood and cerebrospinal fluid is very useful in aiding diagnosis (causes of meningitis), and assessing prognosis and response to treatment in severe malaria and sepsis.5 Out of normal working hours, we use a handheld BM meter (Boehringer Mannheim Accusport 1488767) with BM-Lactate test strips (Roche Diagnostics, Mannheim, Germany) for this purpose. Recently we noticed a discrepancy between the clinical picture, the readings obtained with this meter, and those obtained from our internal quality control. Close inspection of the BM-Lactate test strips revealed that the expiry dates on the strips themselves, the package inserts, and the boxes had been tampered with, such that they appeared to expire in 2004, when in fact they had expired in 2002 (figure). After thorough discussions with all parties involved, this expiry date alteration clearly arose when the product was distributed via loose networks out of the control of the parent companies or licensing authorities. This finding could have implications for how companies distribute and sell their products in certain markets. Compared with drug counterfeiting, this method of fraud is cheap and technically simple, yet at least as difficult to spot and potentially dangerous, particularly if applied to drugs as well as to consumables. The quality of the changes suggests that this fraud is well organised and potentially widespread.
5
Kapp C. Counterfeit drug problem “underestimated”, says conference. Lancet 2002; 360: 1080. Newton P, Proux S, Green M, et al. Fake artesunate in southeast Asia. Lancet 2001; 357: 1948–50. Chatterjee P. India’s trade in fake drugs— bringing the counterfeiters to book. Lancet 2001; 357: 1776. Newton PN, Dondorp A, Green M, Mayxay M, White NJ. Counterfeit artesunate antimalarials in southeast Asia. Lancet 2003; 362: 169. Day NP, Phu NH, Mai NT, et al. The pathophysiologic and prognostic significance of acidosis in severe adult malaria. Crit Care Med 2000; 28: 1833–40.
Sir—Roche Diagnostics is extremely concerned about the discovery of fraud involving one of our products in Vietnam. We have been in communication with Jeremy Day and colleagues, and share their alarm at the discovery of product tampering. Counterfeiting and package tampering are issues that health-care suppliers in Asia are grappling with now. Thanks to the vigilance of the staff at the Hospital for Tropical Diseases, the removal of expiry dates and replacement with new, false dates was discovered. Roche Diagnostics views the fraudulent alteration of expiry dates on diagnostic kits extremely seriously. As a result of local investigations in Vietnam, we believe we have identified the external party responsible for the expiry alteration and are working with local authorities and regulators to address the problem. We have also redefined local logistical processes to minimise the risk of similar fraudulent alterations in the future. Although we hope that no other health-care supplier or medical professional will face the situation that we and the staff at the Hospital for Tropical Diseases in Vietnam have encountered, we feel it is vital to ensure that other members of the industry are informed of incidents such as this and are able to heighten their own vigilance to ensure that patients are not harmed by these fraudulent tactics. Graham Watt Roche Diagnostics Asia Pacific, 15 Rakino Way, Mt Wellington, Auckland, New Zealand (e-mail: [email protected])
THE LANCET • Vol 363 • January 10, 2004 • www.thelancet.com
For personal use. Only reproduce with permission from The Lancet publishing Group.